FDA classifies Medtronic's surgical device as a Class I recall

by Olga Deshchenko, DOTmed News Reporter | November 02, 2010
The U.S. Food and Drug Administration moved to classify Medtronic's Octopus Nuvo Tissue Stabilizer as a Class I recall, the company announced late last week.

The agency deems a product a Class I recall when it is "a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death," according to the FDA.

The Minneapolis, Minn.- based Medtronic voluntarily recalled the surgical device used in minimally invasive heart surgery on Sept. 14 after discovering the possibility of a piece of the device fracturing during use. The piece could potentially fall into the patient's chest cavity or damage the heart tissue during an operation, the company said in a release.

According to Medtronic, 571 of the devices were distributed to health care facilities in the U.S., Europe and Canada. All of the facilities were notified of the recall, the company said.

Medtronic received two reports of the device failing, the company said, incidents that required physicians to remove pieces of the device from the surgical wound. Neither event resulted in permanent damage or death.

"Health care facilities should immediately discontinue use of the device and return all unused Octopus Nuvo Tissue Stabilizer devices to Medtronic," the company said in the release.